NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Phase I/Ib trial evaluating the safety and efficacy of BET inhibitor, ZEN003694 with PD-1 inhibitor, nivolumab with or without CTLA-4 inhibitor, ipilumumab in solid tumors

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000783-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women

Keywords

Immunotherapy;
Rational Drug Combination;
Immune Checkpoint;
Epigenetic Drug Approach

Recruitment Keyword(s)

None

Condition(s)

Advanced Ovarian Cancer;
Metastatic Cancer

Investigational Drug(s)

ZEN003694

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Nivolumab
Biological/Vaccine: Ipilimumab
Drug: ZEN003694

Supporting Site

National Cancer Institute

Background:

Tumors that come back after treatment or spread throughout the body have a high risk of death. Epithelial ovarian cancer, in particular, is highly lethal: 63% of the women diagnosed with this disease in 2018 died. More effective treatments are needed.

Objective:

To test a study drug (ZEN003694) combined with two other drugs (nivolumab and ipilimumab) in people with advanced solid tumors or ovarian cancer.

Eligibility:

People aged 18 years and older who have a solid tumor or ovarian cancer. The cancer must have spread to other parts of the body and/or not responded to previous treatment.

Design:

Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. Imaging scans will be taken. They will have a biopsy of their tumor.

Participants will take study drugs in 28-day cycles. They will take ZEN003694 as a capsule by mouth every day in the morning.

On the first day of each cycle, participants will get nivolumab; this drug is administered through a needle in a vein in the arm over 30 minutes. Some participants will also receive a third drug, ipilimumab, through a needle in a vein in the arm over 90 minutes. They will receive ipilimumab a maximum of 4 times.

Participants may continue with study treatment as long as the drugs are helping them.

Blood tests will be repeated throughout the study. Imaging scans will be repeated every 8 weeks.

Participants will have follow-up visits for up to a year after their last study treatment.

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Eligibility

ELIGIBILITY CRITERIA:

-Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective

--Dose escalation: Metastatic or recurrent solid tumors with measurable or evaluable disease

--Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within <6 months from prior platinum-based therapy

--Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

-No more than 5 lines of prior therapy for the dose escalation and expansion phases

-In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed

-Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort

-Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible.

-Age >=18 with ECOG <= 1

-Women of child-bearing potential


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Naoko Takebe, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 8D53
10 CENTER DR
BETHESDA MD 20892
(240) 541-4515
takeben@mail.nih.gov

Nancy Moore, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D53
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6045
nancy.moore@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04840589

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Phase I/Ib trial evaluating the safety and efficacy of BET inhibitor, ZEN003694 with PD-1 inhibitor, nivolumab with or without CTLA-4 inhibitor, ipilumumab in solid tumors

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000783-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women

Keywords

Immunotherapy;
Rational Drug Combination;
Immune Checkpoint;
Epigenetic Drug Approach

Recruitment Keyword(s)

None

Condition(s)

Advanced Ovarian Cancer;
Metastatic Cancer

Investigational Drug(s)

ZEN003694

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Nivolumab
Biological/Vaccine: Ipilimumab
Drug: ZEN003694

Supporting Site

National Cancer Institute

Background:

Tumors that come back after treatment or spread throughout the body have a high risk of death. Epithelial ovarian cancer, in particular, is highly lethal: 63% of the women diagnosed with this disease in 2018 died. More effective treatments are needed.

Objective:

To test a study drug (ZEN003694) combined with two other drugs (nivolumab and ipilimumab) in people with advanced solid tumors or ovarian cancer.

Eligibility:

People aged 18 years and older who have a solid tumor or ovarian cancer. The cancer must have spread to other parts of the body and/or not responded to previous treatment.

Design:

Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. Imaging scans will be taken. They will have a biopsy of their tumor.

Participants will take study drugs in 28-day cycles. They will take ZEN003694 as a capsule by mouth every day in the morning.

On the first day of each cycle, participants will get nivolumab; this drug is administered through a needle in a vein in the arm over 30 minutes. Some participants will also receive a third drug, ipilimumab, through a needle in a vein in the arm over 90 minutes. They will receive ipilimumab a maximum of 4 times.

Participants may continue with study treatment as long as the drugs are helping them.

Blood tests will be repeated throughout the study. Imaging scans will be repeated every 8 weeks.

Participants will have follow-up visits for up to a year after their last study treatment.

--Back to Top--

Eligibility

ELIGIBILITY CRITERIA:

-Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective

--Dose escalation: Metastatic or recurrent solid tumors with measurable or evaluable disease

--Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within <6 months from prior platinum-based therapy

--Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

-No more than 5 lines of prior therapy for the dose escalation and expansion phases

-In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed

-Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort

-Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible.

-Age >=18 with ECOG <= 1

-Women of child-bearing potential


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Naoko Takebe, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 8D53
10 CENTER DR
BETHESDA MD 20892
(240) 541-4515
takeben@mail.nih.gov

Nancy Moore, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D53
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6045
nancy.moore@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04840589

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